Zantac Cool Mint

Generic Name: ranitidine

Dosage Form: tablet, coated
Zantac Drug Facts

Drug Facts

Active ingredient (in each tablet)	Purpose
Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)....................................	Acid reducer

Uses

• relieves heartburn associated with acid indigestion and sour stomach


• prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

• with other acid reducers


• if you have kidney disease, except under the advice and supervision of a doctor


• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

• nausea or vomiting


• stomach pain


• unexplained weight loss


• frequent chest pain


• frequent wheezing, particularly with heartburn


• had heartburn over 3 months. This may be a sign of a more serious condition.


• heartburn with lightheadedness, sweating or dizziness


• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

• your heartburn continues or worsens


• you need to take this product for more than 14 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and over:
  
  • to relieve symptoms, swallow 1 tablet with a glass of water
  
  
  • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
  
  
  • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
  
  
  • do not chew tablet
  
  


• children under 12 years: ask a doctor

Other information

• Blister: do not use if individual blister unit is open or torn
  
  Bottle: do not use of printed foil under bottle cap is open or torn


• store at 20°-25°C (68°-77°F)


• avoid excessive heat or humidity


• this product is sodium and sugar free

Inactive ingredients

carrageenan, FD&C blue no.1, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,polysorbate, sucralose, and titanium dioxide

Questions?     call 1-888-285-9159 or visit www.zantacotc.com

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.

Dist: Boehringer Ingelheim Consumer Health Care Products Division of Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 ©2009

ZANTAC  150 COOL MINT TABLETS ranitidine  tablet, coated

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0597-0120 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ranitidine hydrochloride (ranitidine) ranitidine hydrochloride 168 mg

Inactive Ingredients Ingredient Name Strength carrageenan   FD&C Blue No. 1   hypromellose   magnesium stearate   cellulose, microcrystalline   polyethylene glycol   polysorbate 80   sucralose   titanium dioxide

Product Characteristics Color BLUE (BLUE) Score no score Shape PENTAGON (5 sided) Size 4mm Flavor MINT (MINT) Imprint Code Z;150 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0597-0120-24 3 BLISTER PACK In 1 BOX contains a BLISTER PACK 1 8 TABLET In 1 BLISTER PACK This package is contained within the BOX (0597-0120-24) 2 0597-0120-38 1 BLISTER PACK In 1 BOX contains a BLISTER PACK 2 8 TABLET In 1 BLISTER PACK This package is contained within the BOX (0597-0120-38) 3 0597-0120-50 1 BOTTLE In 1 BOX contains a BOTTLE 3 50 TABLET In 1 BOTTLE This package is contained within the BOX (0597-0120-50) 4 0597-0120-68 1 BOTTLE In 1 BOX contains a BOTTLE 4 65 TABLET In 1 BOTTLE This package is contained within the BOX (0597-0120-68) 5 0597-0120-87 1 BOTTLE In 1 BOX contains a BOTTLE 5 85 TABLET In 1 BOTTLE This package is contained within the BOX (0597-0120-87)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021698	12/21/2006

Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

Establishment
Name	Address	ID/FEI	Operations
DSM Pharmaceuticals		076301910	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Boehringer Ingelheim Promeco S.A de C.V.		812579472	MANUFACTURE

Revised: 05/2009Boehringer Ingelheim Pharmaceuticals, Inc.

More Zantac Cool Mint resources

• Zantac Cool Mint Use in Pregnancy & Breastfeeding
• Drug Images
• Zantac Cool Mint Drug Interactions
• Zantac Cool Mint Support Group
• 32 Reviews for Zantac Cool Mint - Add your own review/rating

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